AccessGUDID - DEVICE: Physio Logic Digiflex 10 Thermometer (00057565166450)

GUDID

Device Identifier (DI) Information

Brand Name: Physio Logic Digiflex 10 Thermometer
Version or Model: 016-645
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 016-645
Company Name: A.M.G. Médicale Inc

Primary DI Number: 00057565166450
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 207372814 *Terms of Use
Previous DI: 05756516645000

Device Description: Accurate readings in as little as 10 seconds. •Accurate within 0.2 °F / 0.1 °C •Use orally, rectally or underarm •Gentle-flex tip for added comfort & safety. •Fast 10 second reading* •Beep signals peak temperature •Water resistant for easy cleaning •Automatic shut-off feature •Includes storage case

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14035	Intermittent electronic patient thermometer	A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c6559d1b-12aa-4ee9-910a-5d9223cddac7
Public Version Date: August 21, 2020
Public Version Number: 3
DI Record Publish Date: May 16, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05756599953924	24	05756599952248	In Commercial Distribution	Case
05756599952248	12	00057565166450	In Commercial Distribution	Box
10057565166457	12	00057565166450	In Commercial Distribution	Inner box
20057565166454	24	10057565166457	In Commercial Distribution	Master case